Beschreibung
Harvey Nash is looking for a Clinical Trial Leader for a 6 month project in Switzerland.
The candidate is accountable for all aspects of assigned OTM clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT). Number of clinical trials depends on the workload and complexity of the individual trials. You are responsible for
Leading the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible authoring for clinical protocols, amendments and related documents; contributing to the medical/scientific input given for the development of trial-related documents; obtaining approval from internal review boards. Collaborating with the Medical Directors of the Novartis local organizations (CPOs) and investigating to ensure their feedback is adequately integrated into protocol. Contributing to the development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions Investigator/site relationship management is vital; must develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contributing to trial-related advisory boards. Leading investigators meetings. Leading protocol training meetings and supporting CPOs in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s). Leading and Matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizing CTT to adhere to global performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engaging the input of line functions at the appropriate time. Leading trial level interactions with Global Monitoring Operations (GMO) and other relevant functions including Integrated Medical Safety and Drug Supply Management. In collaboration with the CPL leading the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations Preparing and running dose escalation meetings with investigators. Coordinating the Real Time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic and biomarker data, to provide consolidated information for dose escalation meetings with investigators Forecasting trial resources needs (external costs): accountable for the development, management and tracking of trial budget working closely with CRO Management, with Clinical Trial Budget Managers and OTM Global Program Managers. Accountable for accuracy of trial information in all trial databases and tracking systems Ensuring that program specific standards (eg, CRFs, outsourcing specifications, data monitoring and validation plans) are applied to the clinical trial, where applicable Developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties; managing interface with external vendors in cooperation with the CRO Management Department Contributing to the implementation of best practices and standards for trial management, including sharing lessons learned Requirements
4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation. Advanced degree or equivalent education/degree in life science/healthcare strongly recommended. PhD preferred. Advanced degree or equivalent education/degree in life science/healthcare strongly recommended. PhD preferred. Good knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process Basic knowledge of oncology and/or hematology, or experience in early clinical development preferred. Good communication, organization and tracking skills. Fluent English (oral and written) Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred)
For further details feel free to call me. I am looking forward to receiving your application.
